Artes Medical, a San Diego company under investigation for using its wrinkle-filler on people's faces before it was approved for market, yesterday disclosed additional instances of illegal use of its product beyond what it had acknowledged previously.

One of the new cases is a co-founder of the company, Dr. Stefan Lemperle, according to a SEC filing related to the company's planned initial public offering. Lemperle received injections into wrinkles in his face from his father, Dr. Gottfried Lemperle, a plastic surgeon with whom he founded the company.

The company also reported that Stefan Lemperle was removed from his post as chief executive Oct. 26, based on unanimous recommendations from the company's audit, governance and nominating committees.

Gottfried Lemperle, a plastic surgeon, improperly injected 10 people in the United States with some form of the company's wrinkle filler before it was approved for market by the Food and Drug Administration on Oct. 27, the filing states. The people were not part of the sanctioned clinical trials that were necessary to prove the product's worthiness for market.

Stefan Lemperle failed to reveal this to the FDA and the Securities and Exchange Commission, even though the company was notified it was the subject of a criminal investigation.

The company learned earlier this year that the FDA had opened an investigation after receiving complaints that the Lemperles were coaxing people to receive injections of Artefill. At the time the investigation was revealed, the company was defending itself against a fraud lawsuit filed by a woman who claims she suffered disfiguring injuries as a result of Artefill injections.

In a previous filing with the FDA, Artes Medical admitted to four instances of illegal injections.

In July, after touring the company's new manufacturing facility in San Diego, the FDA asked Artes Medical to submit an amended application for market approval of Artefill. The application was to contain all information available about people who had been improperly treated with an Artes Medical product.

That prompted an internal investigation, in which the additional cases were uncovered, the company said in its filing.

The company contends the product improperly used on people was Artecoll, a predecessor product to Artefill, which since has been approved for market. Artecoll has been manufactured and sold by unrelated third parties outside the United States since 1996, the company said.

Gottfried Lemperle since has resigned from his position as chief scientific officer and as a member of the Artes Medical board.

The company said it did not know the status of the criminal investigation. The lawsuit has been postponed until the criminal matter is resolved. An insurance carrier has declined to cover the company in connection with the illegal injections, according to the filing.

“Because he continues to serve as a member of our board of directors, we are in discussions with Dr. Lemperle regarding his future relationship with our company,” the filing states.

The SEC filing also warned that earlier investors in the company might allege that Artes Medical failed to satisfy all requirements of securities laws and that certain disclosures regarding capitalization might not have been accurate or filed properly. Certain offerings might not have come within a private-placement safe harbor, the company states.

To date Artes Medical has raised its money in private investments from more than 800 individual investors. Under securities law, a company that raises more than $1 million from more than 500 investors must register with the SEC and file certain public financial disclosure documents.

The only financial documents the company currently has filed with the SEC pertain to the initial public offering.

The company's lawyers could not be reached for comment yesterday. In the SEC filing, they state that they believe the company has complied with state and federal laws, or that such claims would be barred by statutes of limitation.